BARCELONA -- Findings from two trials suggested the gout drug colchicine may not be all that useful for heart surgery patients, researchers said here.

BARCELONA -- Findings from two trials suggested the gout drug colchicine may not be all that useful for heart surgery patients, researchers said here.

The POPE-2 and COPPS-2 trials had somewhat divergent results, but the message is unified, said Hector Bueno, MD, PhD, of Leiden University Medical Center in the Netherlands, who was not involved in the studies.

"Both studies point in the same direction -- that routine use of colchicine is not justified in [surgical] patients," Bueno told MedPage Today at the European Society of Cardiology meeting. "One is formally negative, the other is slightly positive [and in the latter], the side effects are important enough to question whether the risk balances the benefit of using it routinely."

"They are not totally comparable studies," he added, "but in the end, the final conclusion is very similar, and that is not to use [colchicine] routinely."

In the COPPS-2 study, Massimo Imazio, MD, and colleagues found that giving the drug perioperatively to cardiac surgery patients reduced the incidence of postpericardiotomy syndrome, but it didn't protect against later atrial fibrillation (Afib) or pericardial/pleural effusion, although an on-treatment analysis showed that it did reduce postoperative Afib.

However, a high 20% attrition rate in the study, due largely to gastrointestinal side effects, may have diminished its effects in the intention-to-treat analysis, Imazio said.

When asked how he would practice based on the results of the two studies he conducted -- COPPS and COPPS-2 -- -- he said that considering the side effects, it "might be better to treat instead of prevent this complication."

"The COPPS trial showed that you can use colchicine after surgery with good results, and we have good evidence coming from several trials in pericarditis that it can be used to prevent recurrences, so it is probably better to treat than prevent in this case," Imazio told MedPage Today. "But we have to see if lower doses, maybe 0.5 or 0.6 mg once daily, may be better and better tolerated."

The POPE-2 trial found no effect of colchicine in surgical patients who developed pericardial effusion. This population is at much higher risk of cardiac tamponade than those with postpericardiotomy syndrome, according to investigator Philippe Meurin, MD, of Les Grands Pres in Villeneuve Saint Denis in France.

He and colleagues assessed 197 patients with a postoperative pericardial effusion grade of 2, 3, or 4. They were given colchicine for 14 days, at a dose of 2 mg on the first day followed by a maintenance dose of 1 mg daily in patients who were 70 kg (154 lbs) or greater; those under that weight received 1 mg per day without a loading dose.

They found no difference in the mean decline in pericardial effusion grade (-1.1 for placebo, -1.3 for colchicine, P=0.23).

"Colchicine administration seems to be useless," Meurin told reporters during a press briefing. "And I dare to remind you that [nonsteroidal anti-inflammatory drug or NSAID] administration is also useless."

Gordon Tomaselli, MD, head of cardiovascular medicine at Johns Hopkins Hospital, also expressed caution about the gastrointestinal side effects.

"This, I think, like NSAIDs, is not particularly useful at preventing the important complications that increase the cost of care and delay discharge from the hospital," he told MedPage Today. "And that is the development of pericardial effusion and, importantly, postoperative atrial fibrillation."

The COPPS-2 study was supported by Torino's health service and the Italian National Health Service.

Acarpia provided the study drug and placebo as an unrestricted institutional grant.

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